HIV InfectionPhase 4NCT07895823
Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy - The RELAI Study
A Phase 4 study testing Field-based LA-CAB/RPV in people with HIV Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
Trial summary
Purpose: The purpose of this study is to evaluate the acceptability of field-based long acting cabotegravir/rilpivirine (LA-CAB/RPV) among people with HIV (PWH) who are out of care. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- HIV Infection
- What is being tested?
- Field-based LA-CAB/RPV
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2027to Sep 2028
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- HIV-1 infection documented by at least one of the following at any time prior to study entry:
- any licensed rapid HIV test
- HIV antibody test
- HIV Ag/Ab assay
- HIV-1 antigen, plasma HIV-1 RNA viral assay
- Care provider in the electronic medical record (EMR)
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- Adult men or women ≥ 18 years of age.
- Able and willing to give written informed consent.
- Able and willing to stay in contact with study staff during the duration of the trial.
- Able and willing to provide adequate locator information.
- Able to communicate in English.
- Currently residing in North Carolina.
- Able and willing to comply with all study requirements through duration of the trial.
- Previously received HIV care at the UNC Infectious Disease clinic
- No documented receipt of HIV care including in person or telemedicine visits in the 9 months prior to screening.
- No reported receipt of Antiretroviral therapy (ART) from a provider outside of the UNC Infectious Diseases clinic in the 9 months prior to screening.
- Willing to accept field-based injections of LA-CAB/RPV.
- Women of childbearing potential must agree not to participate in a conception process (e.g., active attempt to become pregnant or to impregnate, sperm donation, in vitro fertilization, egg donation) while taking study medications
Who cannot join
- Women who are pregnant or breastfeeding.
- Any past use of LA-CAB/RPV for HIV treatment.
- Use of concomitant medications with a known risk of Torsade de Pointes including: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, diopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozidine, probucol, procanimide, quinidine, sotalol, sparfloxacxin, terfenadine, thioridizine.
- Use of prohibited medications including anticonvulsants, anti-mycobacterials, or systemic dexamethasone.
- History of liver cirrhosis
- History of estimated glomerular filtration rate (eGFR) <30, determined by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-Epi) equation found at: https://www.mdcalc.com/calc/3939/ckd-epi-equations-glomerular-filtration-rate-gfr
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- Prior evidence of chronic Hepatitis B virus (HBV) infection, defined as positive hepatitis B surface antigen OR positive hepatitis B core antibody and negative hepatitis B surface antibody prior to enrollment.
- History of severe hepatic impairment (Child-Pugh Class C).
- Prior history of virologic failure on a non-nucleoside reverse transcriptase inhibitor (NNRTI)-based ART regimen
- History of major resistance-associated mutation (RAM) to any non-nucleoside reverse transcriptase inhibitor (NNRTI) on prior HIV genotype testing according to International Antiviral Society (IAS) criteria.
- History of a major RAM to an integrase strand inhibitor (INSTI) on prior HIV genotype testing according to IAS criteria.
- Known or suspected NNRTI or INSTI resistance. NOTE: in the absence of genotype data, clinical judgement based on prior regimens and response will be applied to determine suspected resistance.
- Any serious illness requiring systemic treatment or hospitalization, the participant must either complete therapy or be clinically stable on therapy, in the opinion of the site investigator, for at least 90 days prior to enrollment.
- Known allergic reactions to components of study treatment, specifically cabotegravir or rilpivirine.
- Use of any other investigational treatment within 6 months prior to enrollment.
- Any medical, psychiatric, substance abuse, occupational or other condition that, in the judgment of the investigator, would interfere with, or serve as a contraindication to, protocol adherence or assessment of safety.
- Current incarceration.
- Inability to communicate effectively with study personnel.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
Sarah Rutstein, MD, PHD, 919-966-2537, sarah_rutstein@med.unc.edu
About this study
Official title: IGHID 12616 - Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy (RELAI) - The RELAI Study
Purpose: The purpose of this study is to evaluate the acceptability of field-based long acting cabotegravir/rilpivirine (LA-CAB/RPV) among people with HIV (PWH) who are out of care.
Participants: 40 adult men and women living with HIV will be enrolled
Procedures (methods): This is a pilot, open-label study to evaluate the acceptability, feasibility, and virologic impact of field-based LA-CAB-RPV for PWH who are out of care. This study will enroll 40 participants who accept field-based LA-CAB-RPV, targeting >50% who reside in rural or semi-rural counties. Participants will be followed for 7 months, with duration of follow-up selected based on the FDA approved every 2 month LA-CAB-RPV injection schedule for virally suppressed patients, aligning with the 5th injection for an every two-month cycle
- Conditions
- HIV Infection
- Being tested
- Field-based LA-CAB/RPV
- Keywords
- LA-CAB/RPV, HIV care
- Medical subject headings
- HIV Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Field-based LA-CAB/RPVDrug
Participants will receive their first does of long-acting cabotegravir 600 mg and rilpivirine 900 mg by separate intramuscular gluteal injections on Day 0 in a secure, community-based location of their choosing (such as their home). Additional field-based injections will be available at Week 4, and then every 2 months at Weeks 12, 20, and 28, though participants can instead choose to receive injections in the clinic instead.
| Study group | Role | What they receive |
|---|---|---|
| Field-based LA-CAB/RPV | Experimental | Not described Receives: Drug: Field-based LA-CAB/RPV |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percent of preliminarily eligible participants who accept and receive field-based injection (acceptability)
Measured: From enrollment to the end of participation at 7 months
Median acceptability of intervention (AIM) score (acceptability)
AIM scores are calculated using the following scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scores are calculated from a version of the following four questions: (1) The intervention meets my approval, (2) The intervention is appealing to me, (3) I like the intervention, and (4) I welcome the intervention. Scores are summed across participant and summaries of these scores are provided, minimum score is 4 and maximum score is 20 which corresponds to perfect acceptability.
Measured: Month 3, Month 7
Median HIV treatment burden score (acceptability)
The Treatment burden Questionnaire (TBQ) is a self-reported questionnaire assessing the burden of treatment without restricting its scope to a single condition or treatment context. It has been adapted to include 13 items rated on a Likert scale ranging from 0 (not at all difficult) to 5 (extremely difficult) related to the burden associated with taking medicine, self-monitoring, laboratory tests, physician visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment. Item scores can be summed into a global score, ranging from 13 to 65. Higher scores reflect higher treatment burden.
Measured: Month 0, Month 3, Month 7
Percentage of participants who receive all indicated LA-CAB/RPV injections within the allowable 14-day window (feasibility)
As extracted from study administration and, where appropriate, clinic records, the date of injections will be determined as falling within or outside the acceptable window period. This outcome will be calculated as the percent of all participants with an indication for receipt of LA-CAB/RPV (that is, has not been excluded from further injections identified after receipt of first injection or failure to achieve appropriate decline in HIV RNA levels or viral suppression prompting transition to alternative agent), who receive all indicated injections within the acceptable 14-day window period, as determined by the date of the prior injection.
Measured: From enrollment to the end of participation at 7 months
Secondary outcomes (6)
Percentage of participants with HIV RNA <200 copies/mL at 7 months (viral suppression)
Among all participants with HIV RNA available within allowable final study visit window (week 28) (obtained through study procedures or clinical care), percent with HIV RNA <200 copies/mL. Participants without HIV RNA available within allowable final study visit window (week 28), and for whom >2 months have elapsed since their last injection at the end of closure of that window will be assumed to have HIV RNA >200 copies/mL.
Measured: Month 7
Percentage of participants with HIV RNA <200 copies/mL at their end of study visit (viral suppression)
among all participants based on their final study visit, regardless of retention in study procedures through 7-month follow-up, percent with HIV RNA <200 at their final study visit.
Measured: From enrollment through end of study (month 7)
Percentage of participants with viremia >200 copies/mL at enrollment who suppress to <200 copies/mL by month 7 (viral suppression)
Among participants who have an HIV RNA >200 copies/mL on D0, the percent who have at least one HIV RNA <200 copies/mL during follow-up evaluations through month 7.
Measured: From enrollment through end of study (month 7)
Percentage of participants with a HIV clinic visit within 7 months from enrollment on study (re-engagement)
Among all enrolled persons, what percent attended at least one clinic visit (in-person or virtual) with a non-study affiliated primary HIV provider within 7-month follow-up period.
Measured: From enrollment through end of study (month 7)
Percentage of eligible PWH contacted (recruitment and engagement)
Among persons with HIV who are pre-screened as eligible and with at least one contact attempt made by study staff, what percent are contacted (defined as speaking to person directly, receiving response back via text or preferred messaging medium, or encountering in-person), regardless of persons eventual eligibility or screening outcomes.
Measured: from screening to end of recruitment (~12 months)
Percentage of contacted PWH who are screened for the study (recruitment and engagement)
Among persons with HIV who are contacted (defined as having at least one contact made by staff including speaking to person directly, receiving response back via text or preferred messaging medium, or encountering in-person), what percent undergo screening for study eligibility
Measured: from screening to end of recruitment (~12 months)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2026
- Study startJan 2027 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HIV InfectionStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- ViiV Healthcare, National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Sarah Rutstein, MD, PhD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07895823
- Sponsor's protocol ID
- 26-1611
- Other IDs
- 1R34MH139436-01A1
- Status last verified
- Sep 2026
- First submitted
- 19 Oct 2026
- Last updated
- 26 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- IGHID 12616 - Reaching Persons With HIV Who Are Out of Care Through Expedited Access to Long-Acting Injectable Antiretroviral Therapy (RELAI) - The RELAI Study
- ClinicalTrials.gov ID
- NCT07895823
- Acronym / sponsor ID
- 26-1611
- Conditions
- HIV Infection
- Keywords
- LA-CAB/RPV, HIV care
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- ViiV Healthcare, National Institute of Mental Health (NIMH)
- Study start
- Jan 2027 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 26 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: The purpose of this study is to evaluate the acceptability of field-based long acting cabotegravir/rilpivirine (LA-CAB/RPV) among people with HIV (PWH) who are out of care.
Participants: 40 adult men and women living with HIV will be enrolled
Procedures (methods): This is a pilot, open-label study to evaluate the acceptability, feasibility, and virologic impact of field-based LA-CAB-RPV for PWH who are out of care. This study will enroll 40 participants who accept field-based LA-CAB-RPV, targeting >50% who reside in rural or semi-rural counties. Participants will be followed for 7 months, with duration of follow-up selected based on the FDA approved every 2 month LA-CAB-RPV injection schedule for virally suppressed patients, aligning with the 5th injection for an every two-month cycle
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Field-based LA-CAB/RPV | Experimental | Drug: Field-based LA-CAB/RPV |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- HIV-1 infection documented by at least one of the following at any time prior to study entry:
- Adult men or women ≥ 18 years of age.
- Able and willing to give written informed consent.
- Able and willing to stay in contact with study staff during the duration of the trial.
- Able and willing to provide adequate locator information.
Key exclusion criteria (18 listed)
- Women who are pregnant or breastfeeding.
- Any past use of LA-CAB/RPV for HIV treatment.
- Use of concomitant medications with a known risk of Torsade de Pointes including: amiodarone, arsenic trioxide, astemizole, bepridil, chloroquine, chlorpromazine, cisapride, clarithromycin, diopyramide, dofetilide, domperidone, droperidol, erythromycin, halofantrine, haloperidol, ibutilide, levomethadyl, mesoridazine, methadone, pentamidine, pimozidine, probucol, procanimide, quinidine, sotalol, sparfloxacxin, terfenadine, thioridizine.
- Use of prohibited medications including anticonvulsants, anti-mycobacterials, or systemic dexamethasone.
- History of liver cirrhosis
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Field-based LA-CAB/RPVParticipants will receive their first does of long-acting cabotegravir 600 mg and rilpivirine 900 mg by separate intramuscular gluteal injections on Day 0 in a secure, community-based location of their choosing (such as their home). Additional field-based injections will be available at Week 4, and then every 2 months at Weeks 12, 20, and 28, though participants can instead choose to receive injections in the clinic instead. | Drug | Field-based LA-CAB/RPV |
Primary outcome
Percent of preliminarily eligible participants who accept and receive field-based injection (acceptability)
Time frame: From enrollment to the end of participation at 7 months
Median acceptability of intervention (AIM) score (acceptability)
Time frame: Month 3, Month 7
AIM scores are calculated using the following scale: 1 = Completely disagree, 2 = Disagree, 3 = Neither agree nor disagree, 4 = Agree, 5 = Completely agree. Scores are calculated from a version of the following four questions: (1) The intervention meets my approval, (2) The intervention is appealing to me, (3) I like the intervention, and (4) I welcome the intervention. Scores are summed across participant and summaries of these scores are provided, minimum score is 4 and maximum score is 20 which corresponds to perfect acceptability.
Median HIV treatment burden score (acceptability)
Time frame: Month 0, Month 3, Month 7
The Treatment burden Questionnaire (TBQ) is a self-reported questionnaire assessing the burden of treatment without restricting its scope to a single condition or treatment context. It has been adapted to include 13 items rated on a Likert scale ranging from 0 (not at all difficult) to 5 (extremely difficult) related to the burden associated with taking medicine, self-monitoring, laboratory tests, physician visits, need for organization, administrative tasks, following advice on diet and physical activity, and social impact of the treatment. Item scores can be summed into a global score, ranging from 13 to 65. Higher scores reflect higher treatment burden.
Percentage of participants who receive all indicated LA-CAB/RPV injections within the allowable 14-day window (feasibility)
Time frame: From enrollment to the end of participation at 7 months
As extracted from study administration and, where appropriate, clinic records, the date of injections will be determined as falling within or outside the acceptable window period. This outcome will be calculated as the percent of all participants with an indication for receipt of LA-CAB/RPV (that is, has not been excluded from further injections identified after receipt of first injection or failure to achieve appropriate decline in HIV RNA levels or viral suppression prompting transition to alternative agent), who receive all indicated injections within the acceptable 14-day window period, as determined by the date of the prior injection.
6 secondary outcomes
Percentage of participants with HIV RNA <200 copies/mL at 7 months (viral suppression)
Time frame: Month 7
Percentage of participants with HIV RNA <200 copies/mL at their end of study visit (viral suppression)
Time frame: From enrollment through end of study (month 7)
Percentage of participants with viremia >200 copies/mL at enrollment who suppress to <200 copies/mL by month 7 (viral suppression)
Time frame: From enrollment through end of study (month 7)
Percentage of participants with a HIV clinic visit within 7 months from enrollment on study (re-engagement)
Time frame: From enrollment through end of study (month 7)
Percentage of eligible PWH contacted (recruitment and engagement)
Time frame: from screening to end of recruitment (~12 months)
Percentage of contacted PWH who are screened for the study (recruitment and engagement)
Time frame: from screening to end of recruitment (~12 months)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 and continuing for 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Sarah Rutstein, MD, PhD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Field-based LA-CAB/RPV in people with HIV Infection, run by University of North Carolina, Chapel Hill at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sarah Rutstein, MD, PhD (919-843-5859, sarah_rutstein@med.unc.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percent of preliminarily eligible participants who accept and receive field-based injection (acceptability) (time frame: From enrollment to the end of participation at 7 months). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2026.